ISO 13485:2016 Lead Auditor Training Course

This course teaches the key principles and practices of effective quality management system audits in accordance with ISO 13485:2016 and ISO 19011, “Guidelines for auditing management systems”. Experienced instructors guide students through the entire audit process, from managing an audit programme to reporting on audit results. Participants will gain the knowledge and skills to plan, conduct, report and follow up a QMS audit that establishes conformity and enhances overall organizational performance. 

Who should attend?

  • Medical device quality professionals interested in conducting first-party, second-party, and/or third-party audits
  • Management representatives
  • Quality directors, managers, and engineers
  • Consultants

Do you already have a good knowledge of ISO 13485:2016?

If not, we highly recommend you take our ISO 13485:2016 Clause by Clause training course first as there are particular requirements you need to understand before you can be an auditor.

"We are proud to have the standard. It gives us enormous credibility with our potential customer base and with that credibility we give them confidence."

What will I learn?

On completion of this training, participants will be able to:

  • Gain the skills to plan, conduct, report and follow up an audit in accordance with ISO 19011
  • Identify the purpose and benefits of an ISO 13485:2016 QMS
  • Explain the role of an auditor in planning, conducting, reporting and following up an audit in accordance with ISO 19011 (and ISO 17021 where appropriate).

How will I benefit?

  • Identify the aims and benefits of an ISO 13485:2016 audit
  • Interpret ISO 13485:2016 requirements for audit application
  • Plan, conduct and follow-up auditing activities that add real value
  • Grasp the application of risk-based thinking, leadership and process management
  • Access the latest auditor techniques and identify appropriate use
  • Build stakeholder confidence by managing processes in line with the latest requirements
  • Understand the arrangements for BSI certification

What's included?

The residential and non-residential courses both include: 

  • You will gain 40 CPD points on completing the course
  • Course notes
  • Lunch 
  • Refreshments

The residential option also includes 4 nights accommodation and evening meals from the first day of the course.

 


COVID-19: Important information on classroom-based training courses

BSI is closely monitoring UK Government Advice regarding the safety of classroom-based training courses. In the event of a classroom-based course being deemed unsafe, your training booking will be automatically transferred to online delivery using our highly-interactive virtual classroom - Connected Learning Live.

If you have any questions regarding your booking, please contact training@bsigroup.com or call +44 345 086 9000.


Book an online course

Experience our highly-interactive virtual classroom with live online training courses via Connected Learning Live. Use the code CLL2020 on a course date taking place before 3 July 2020, and you'll save 15% on your booking fee.

 

Book ONLINE course now >